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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ceritinib
Trade Name: ZYKADIA
Date Designated: 09/27/2013
Orphan Designation: Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: ceritinib
Trade Name: ZYKADIA
Marketing Approval Date: 04/29/2014
Approved Labeled Indication: ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic nonsmall cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Exclusivity End Date: 04/29/2021 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
2 Generic Name: ceritinib
Trade Name: ZYKADIA
Marketing Approval Date: 05/26/2017
Approved Labeled Indication: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
Exclusivity End Date: 05/26/2024 
Exclusivity Protected Indication* :  Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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